FDA Rejects 34 Firms’ E-Cigarette Applications

The agency said the marketing denial orders cover about 355,000 products.

September 08, 2021

ALEXANDRIA, Va.—The Food and Drug Administration (FDA) said it has denied marketing applications for flavored electronic nicotine delivery system (ENDS) products submitted by 34 companies, representing about 355,000 products.

The agency issued marketing denial orders (MDOs) to 31 companies from August 27 through September 2 and three companies on August 26.

The FDA said it has received premarket applications for deemed new tobacco products from more than 500 companies covering more than 6.5 million tobacco products. It is still working down the list of reviewing the applications it received by September 2020 court-ordered deadline for submission of premarket applications for deemed new tobacco products. 

The FDA required makers of e-cigarettes to submit premarket applications by Sept. 9, 2020, and retailers were allowed to keep selling these products for a year from the date of the deadline while the FDA reviews applications, or until the agency issues an MDO or take other negative action

“Congress gave the FDA the authority to regulate tobacco products to protect the public from the harmful effects of tobacco use through science-based regulation,” said Acting FDA Commissioner Janet Woodcock, M.D. “Ensuring new tobacco products undergo an evaluation by the FDA is a critical part of our aim to reduce tobacco-related disease and death. We know that flavored tobacco products are very appealing to young people, therefore assessing the impact of potential or actual youth use is a critical factor in our decision-making about which products may be marketed.”

FDA said the products that the agency denied can’t be introduced or delivered for introduction into interstate commerce. If the product is already on the market, the product must be removed from the market or risk enforcement, the agency said. The affected companies may have submitted other premarket applications for additional tobacco- or menthol-flavored products, and those applications remain under review.

Several of the MDOs were issued to companies that are not confirmed to be currently marketing their products, the FDA said, noting that it can’t release additional information about those companies.

View information on the companies that have received an MDO here.

NACS has requested a list of the specific products that are not approved so retailers can remove them. The FDA has responded that they cannot provide that list, notes Lyle Beckwith, senior vice president, government relations, NACS. “Knowing that this in an unsatisfactory response for retailers, we then inquired whether the enforcement would occur at the retail or manufacturer level and are awaiting a response,” Beckwith said.

In May, the FDA posted the list of deemed new tobacco products for which manufacturers submitted a premarket application to the agency via the Premarket Tobacco Product Application (PMTA) pathway by Sept. 9, 2020. The list includes more than six million products.